Senior Manager, US Compliance

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

The Sr. Manager of US Compliance is a key member of our Compliance team who will support our commercial and medical operations and be based in Boston. This is an opportunity to further develop a best-in-class compliance program in the U.S. as a member of a dynamic team poised for growth, with cross-functional work with teams in Europe and Asia. The Sr. Manager of US Compliance’s responsibilities will include developing policies and other written standards, developing training materials, executing auditing and monitoring activities, and other general compliance activities, including fostering the strong ethical culture of argenx.

Roles and Responsibilities:

1. Support and conduct routine and risk-based monitoring and auditing of relevant US business activities and related policies and procedures; assist in and oversee the implementation of corrective action plans as necessary; and generate and deliver reports to leadership on monitoring, auditing and risk assessment.
2. Advise regarding compliance obligations and continue to evolve the global compliance program in the US and ensure that it is consistent with the values and principles of the organization, fit for purpose and complies with applicable legal and regulatory requirements.
3. Serve as an advisor to US commercial and medical teams to provide compliance-based input and direction across product portfolio.
4. Draft and implement appropriate policies, in collaboration with the Head of US Compliance, legal and other compliance colleagues, to ensure compliance with applicable laws, regulations and codes applicable in the US (excluding cGMP, cGCP and other GxP guidelines).
5. Support adherence to US transparency reporting requirements and reporting obligations.
6. Conduct or assist in compliance-related investigations and other allegations of misconduct, as required.
7. Prepare and deliver compliance training and education to the US organization, with particular emphasis on field-based employees, to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures.
8. Other duties as assigned.

Skills and Competencies:

1. Strong interpersonal and oral and written communication skills; a collaborator who communicates in an open, clear, complete, timely and consistent manner.
2. Shows flexibility and is open to change in a growing, multi-cultural environment; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the company’s business and culture.
3. Team-player, able to work well with others and communicate with cross-functional colleagues and senior leadership.
4. Able to innovate, analyze and solve problems with minimal supervisory input, anticipating and identifying compliance and other business risks; capable of strategic thinking and proposing innovative solutions to compliance-related challenges.
5. Solid understanding of business goals and legal, compliance and regulatory landscape in the US.
6. High degree of personal, professional and corporate ethics, integrity and responsibility.
7. Knowledge of and proficiency with laws and regulations applicable to global pharmaceutical companies, including among other things, the US Foreign Corrupt Practices Act, US fraud and abuse and false claims laws and PhRMA Code on Interactions with Healthcare Professionals.
8. Comfortable in a results-driven, highly accountable environment where you can make a clear impact; consistently shows initiative, and willing and able to take high levels of responsibility for complex initiatives.

Education, Experience and Qualifications:

1. 5-7 years of biopharmaceutical industry experience in a relevant compliance function, with extensive experience within a commercial stage pharmaceutical or biotech company.
2. BA/BS required; other relevant accreditations or degrees considered.
3. Experience with launching new products and/or new indications, healthcare compliance systems, training employees, engagement of healthcare professionals and transparency are all essential.
4. Expertise in the areas of US corporate commercial healthcare law and regulation, including with respect to healthcare fraud and abuse laws, US transparency laws and regulations, privacy laws, anti-bribery laws, and other laws and regulations related to the development and commercialization of pharmaceutical products.
5. Expertise in the PhRMA Code on Interactions with Healthcare Professionals and other relevant industry codes and guidelines.
6. Travel 25-30%.